BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEEL-AWAY INTRODUCER KIT 11F, .038, 14CM SHEATH

    MDR report key: 303420 · Received November 2, 2000

    Report

    Report Number
    2182269-2000-00150
    Event Type
    Other
    Date Received
    November 2, 2000
    Date of Event
    October 3, 2000
    Report Date
    November 2, 2000
    Manufacturer
    ST. JUDE MEDICAL DAIG DIVISION
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF A PACEMAKER, A 6-8 CM PORTION OF THE PEEL-AWAY INTRODUCER SHEATH SPLIT CIRCUMFERENTIALLY AND REMAINS IN THE PT'S RIGHT SUBCLAVIAN ARTERY. THE PHYSICIAN HAS ELECTED NOT TO INTERVENE. THEREFORE, A PORTION OF THE SHEATH REMAINS IN THE PT. THE PT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEL-AWAY INTRODUCER KIT 11F, .038, 14CM SHEATH PEEL-AWAY KIT 11F, 14CM DYB ST. JUDE MEDICAL DAIG DIVISION 405124 97BY05

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other